A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone
Objectives: We sought to validate Cognitive Research Corporation’s Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability. Methods: A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in ran...
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| Published in | Therapeutic advances in drug safety Vol. 6; no. 3; pp. 86 - 97 |
|---|---|
| Main Authors | , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London, England
SAGE Publications
01.06.2015
Sage Publications Ltd |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2042-0986 2042-0994 |
| DOI | 10.1177/2042098615579314 |
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| Abstract | Objectives:
We sought to validate Cognitive Research Corporation’s Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability.
Methods:
A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design.
Results:
Evening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods.
Conclusions:
Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies. |
|---|---|
| AbstractList | Objectives:We sought to validate Cognitive Research Corporation’s Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability.Methods:A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design.Results:Evening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods.Conclusions:Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies. Objectives: We sought to validate Cognitive Research Corporation’s Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability. Methods: A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design. Results: Evening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods. Conclusions: Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies. We sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability. A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design. Evening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods. Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies. We sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability.OBJECTIVESWe sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability.A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design.METHODSA total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design.Evening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods.RESULTSEvening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods.Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies.CONCLUSIONSFurther validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies. |
| Author | Cha, Jang-Ho Struyk, Arie Stoch, Aubrey Simen, Arthur A. Hochadel, Thomas Heirman, Ingeborg Bleys, Kim Beals, Chan Drexel, Melissa Laethem, Tine Gargano, Cynthia Gheyle, Lien Bautmans, An Kay, Gary G. |
| Author_xml | – sequence: 1 givenname: Arthur A. surname: Simen fullname: Simen, Arthur A. email: arthur.simen@pfizer.com organization: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA 19454, USA. Present address: Pfizer Worldwide Research & Development, Cambridge, MA 02139, USA – sequence: 2 givenname: Cynthia surname: Gargano fullname: Gargano, Cynthia organization: Johnson & Johnson, Springhouse, PA 19477 – sequence: 3 givenname: Jang-Ho surname: Cha fullname: Cha, Jang-Ho organization: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA – sequence: 4 givenname: Melissa surname: Drexel fullname: Drexel, Melissa organization: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA – sequence: 5 givenname: An surname: Bautmans fullname: Bautmans, An organization: Merck ESD EU, MSD Europe Inc., Belgium – sequence: 6 givenname: Ingeborg surname: Heirman fullname: Heirman, Ingeborg organization: Merck ESD EU, MSD Europe Inc., Belgium – sequence: 7 givenname: Tine surname: Laethem fullname: Laethem, Tine organization: Merck ESD EU, MSD Europe Inc., Belgium – sequence: 8 givenname: Thomas surname: Hochadel fullname: Hochadel, Thomas organization: Cognitive Research Corporation, Saint Petersburg, FL, USA – sequence: 9 givenname: Lien surname: Gheyle fullname: Gheyle, Lien organization: SGS Life Science Services, Antwerp, Belgium – sequence: 10 givenname: Kim surname: Bleys fullname: Bleys, Kim organization: SGS Life Science Services, Antwerp, Belgium – sequence: 11 givenname: Chan surname: Beals fullname: Beals, Chan organization: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA – sequence: 12 givenname: Aubrey surname: Stoch fullname: Stoch, Aubrey organization: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA – sequence: 13 givenname: Gary G. surname: Kay fullname: Kay, Gary G. organization: Cognitive Research Corporation, Saint Petersburg, FL, USA – sequence: 14 givenname: Arie surname: Struyk fullname: Struyk, Arie organization: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA |
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We sought to validate Cognitive Research Corporation’s Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving... We sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability. A total... Objectives:We sought to validate Cognitive Research Corporation’s Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving... We sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving... |
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| Title | A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone |
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